Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

NCT ID: NCT02724501

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-04-30

Study Completion Date

2011-10-31

Brief Summary

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This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Detailed Description

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PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Conditions

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Endometrial Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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questionnaire

Using questionnaire to obtain patient's medical and family history of cancer.

Intervention Type BEHAVIORAL

Blood sample-DNA testing / Tumour-genetic markers

Using Samples obtained to produce summary statistics on the tumour markers

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 and older
* patients who had a hysterectomy
* patient able to provide consent and complete questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Trials Group

NETWORK

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Fyles, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Terry Fox Grant #11425

Identifier Type: -

Identifier Source: secondary_id

UHN REB 01-0256-C

Identifier Type: -

Identifier Source: org_study_id